MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER HEMODIALYTSIS NON IMP

Catalog Number CS-25122-F

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the swg was found kinked during used on the patient".No patient harm or injury.The patient status is reported as "fine".

Event Description

It was reported that "the swg was found kinked during used on the patient".No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The report that the guide wire kinked during use was confirmed through examination of the returned sample.The customer provided one image showing a defective guide wire.The complaint of a kinked guide wire was able to be confirmed by the photo.The customer returned one guide wire for analysis.Signs-of-use in the form of biological material were observed on the guide wire body.Visual analysis revealed that the guide wire contained five major kinks on the guide wire body.Two slight bends were also observed.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were full and spherical.The major kinks on the guide wire measured 93mm, 220mm, 530mm, 649mm, and 660mm via calibrated ruler from the proximal weld.The total guide wire length measured 684mm via calibrated ruler, which was within the specification limits of 678mm-687mm per the guide wire product drawing.The guide wire outer diameter measured 0.850mm via calibrated caliper, which was within the specification limits of 0.838mm-0.877mm per the dilator product drawing.Functional inspection was performed per ifu statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The guide wire was advanced through a lab inventory ars/18ga introducer needle subassembly to functionally test the guide wire.Resistance was observed at the locations of the kinking; however, the undamaged portions of the guide wire were able to pass as expected.A manual tug test confirmed that both the distal and proximal welds were intact.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained, and further consultation requested".The returned guide wire met all relevant dimensional and functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18403096
• MDR Text Key: 331501964
• Report Number: 3006425876-2023-01285
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801902100207
• UDI-Public: 00801902100207
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-25122-F
• Device Lot Number: 71F23D0177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1